To investigate the changes in facial- and hand analysis in patients with acromegaly as a result of medical treatment and pituitary surgery, and to investigate the changes in relational proportions between facial- and hand structures, incidence and…
ID
Source
Brief title
Condition
- Endocrine and glandular disorders NEC
- Upper respiratory tract disorders (excl infections)
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Parameters of facial analysis with 3D stereophotography and cone beam CT and
hand analysis with 3D stereophotography respectively, biochemical parameters of
disease activity, disease related and general QOL using the AcroQol and RAND-36
questionnaires, speech analysis and the voice handicap index questionnaire and
severity of sleep apnea using complete overnight polysomnography and the
Epworth sleepiness scale questionnaire.
Secondary outcome
In vitro inflammatory cytokineproduction and foam cell formation of monocytes
obtained from patiënts with acromegaly
Background summary
Acromegaly is the clinical syndrome that results from an excess of growth
hormone (GH). Craniofacial and hand disproportions due to soft tissue swelling
and new bone formation are highly prevalent in patients with active acromegaly.
Besides the cosmetic aspects, these changes can impair the quality of life
because of the significant morbidity with respect to oral, maxillofacial and
hand pathologies as well as respiratory problems such as sleep apnea and
changes in speech. At present it is unclear if these craniofacial and hand
disproportions, sleep apnea and speech changes are (partially) reversible after
successful treatment. Therefore there is no consensus about the information
patients should be given about (partial) recovery of facial and hand
disproportions after treatment and how the follow-up with respect to oral,
maxillofacial, respiratory and hand pathology should be organized. Facial and
hand analysis using a 3D stereophotograph and a 3D fusion model of a 3D
stereophotograph and a 3D skull reconstruction via cone beam computed
tomography (CT)-scan makes it possible to investigate the craniofacial changes
due to acromegaly in all facial dimensions together (dentition, bone and soft
tissue) and the relational proportions between these facial structures. 3D
stereophotography can do the same for the soft tissues of the hand. Combined
with disease specific and general quality of life (QOL) questionnaires, a
correlation between quality of life and craniofacial and hand disproportions
can be determined. Combined with sleep- and speech analysis, a correlation
between sleep apnea, speech and craniofacial disproportions can be determined.
Study objective
To investigate the changes in facial- and hand analysis in patients with
acromegaly as a result of medical treatment and pituitary surgery, and to
investigate the changes in relational proportions between facial- and hand
structures, incidence and severity of sleep apnea and incidence and severity of
speech changes.
Study design
Prospective case-control study.
Study burden and risks
As a result of participating in this study, subjects have to undergo a 3D
stereophotograph and a 3D cone beam CT. The cone beam CT is associated with
exposure to X-ray radiation of 0.069-0.135mSv. This is the same amount of
radiation as the amount of background radiation that each person receives in 7
days time during daily life. No adverse effects are expected from this amount
of exposure. The investigation will take 20-40 minutes adjacent to every
outpatient clinic visit.
Patients undergo venipuncture as part of their standard care. The additional
blood samples required for this study will be obtained during regular
outpatient clinic blood dwaring procedures. Patients will not undergo an
additional venipuncture. Therefore, this addition to the original protocol is
associated with no signifant burden.
Geert Grooteplein-Zuid 8
Nijmegen 6525GA
NL
Geert Grooteplein-Zuid 8
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
- Newly diagnosed acromegaly
- Diagnosis is biochemically confirmed by an increased IGF-1 level (mean +2 standard deviations for age) and insufficient suppression of serum GH levels (e.g. GH levels >= 2mU/l) during oral glucose tolerance test.
- Subjects should be over 18 years old with the ability to read and comprehend the Dutch language
Exclusion criteria
- Pregnancy
- Maxillofacial surgical treatment in the past.
- Hand surgery in the past
- Speech pathology unrelated to acromegaly
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39882.091.12 |